FTI 100 MEDICAL THERMAL IMAGER

FTI 100 MEDICAL THERMAL IMAGER is an FDA 510(k)-cleared medical device (K862416) manufactured by Parexel Intl. Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 30, 1986. Regulation: 8.